Background
Lateral flow device (LFD) viral antigen immunoassays have been developed around the world as diagnostic tests for SARS-CoV-2 infection. They have been proposed to deliver an infrastructure-light, cost-economical solution giving results within half an hour.
Methods
LFDs were initially reviewed by a Department of Health and Social Care team, part of the UK government, from which 64 were selected for further evaluation from 1st August to 15th December 2020. Standardised laboratory evaluations, and for those that met the published criteria, field testing in the Falcon-C19 research study and UK pilots were performed (UK COVID-19 testing centres, hospital, schools, armed forces).
Findings
4/64 LFDs so far have desirable performance characteristics (orient Gene, Deepblue, Abbott and Innova SARS-CoV-2 Antigen Rapid Qualitative Test). All these LFDs have a viral antigen detection of >90% at 100,000 RNA copies/ml. 8951 Innova LFD tests were performed with a kit failure rate of 5.6% (502/8951, 95% CI: 5.1–6.1), false positive rate of 0.32% (22/6954, 95% CI: 0.20–0.48). Viral antigen detection/sensitivity across the sampling cohort when performed by laboratory scientists was 78.8% (156/198, 95% CI 72.4–84.3).
Interpretation
Our results suggest LFDs have promising performance characteristics for mass population testing and can be used to identify infectious positive individuals. The Innova LFD shows good viral antigen detection/sensitivity with excellent specificity, although kit failure rates and the impact of training are potential issues. These results support the expanded evaluation of LFDs, and assessment of greater access to testing on COVID-19 transmission.
Funding
Department of Health and Social Care. University of Oxford. Public Health England Porton Down, Manchester University NHS Foundation Trust, National Institute of Health Research.
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This article assesses the regulatory response to fracking by Saskatchewan, Canada's second largest oilproducing province. Public officials and industry representatives claim fracking regulations are "comprehensive" and "robust"; however, there has been no comparative assessment of this claim. To address this gap, we outline the dominant regulatory pathways of U.S. states and Canadian provinces, ranging from applying existing regulations with minimal revisions, to enacting broader revisions or bans. We account for this variation using a framework from Davis (2012) emphasizing governments' dependence on the oil sector, the level of support for fracking among elected officials and policy makers, and the influence of key "constituencies." The article then traces the growth and impact of fracking in Saskatchewan and analyzes new trends in the province's regulation of fracking. Given the province's application of existing regulations with minimal revisions and active weakening of enforcement, we identify Saskatchewan as taking Rabe and Borick's (2013) "conventional" regulatory approach, typical of Davis's "energy dominant" states.
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